Regulations

Multiple Sclerosis Analytical Report

PatSnap | 15-Jun-2022 | Technical / White Paper

More than 2.3 million people are living with MS worldwide. Although there is no cure, new research and innovative treatments are continuously emerging....

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

High quality services in CDMO: Indena’s leadership in a strategic market

Indena | 16-Mar-2020 | Technical / White Paper

Contract manufacturers are required to heavily invest in building new facilities. Thanks to its strategic choices of investment moves and the adoption...

Make the move to PyroMAT™ System: the only cell line-based Monocyte Activation Test for the detection of pyrogens

Merck KGaA, Darmstadt, Germany | Recorded the 25-Oct-2018 | Webinar

For pharmaceutical companies, patient safety has always been the priority. That’s why pyrogen detection has become a mandatory Quality Control test for...

Enabling drug traceability. Implementing serialization in practice as a CDMO.

R-Pharm Germany GmbH | Recorded the 10-Oct-2017 | Webinar

R-Pharm Germany has established an effective track & trace system to meet all regulatory requirements and to offer cost-effective and customer-oriented...

FDA Focus̶ Product Design and Post Approval Changes

Colorcon Inc. | 19-Sep-2016 | Technical / White Paper

Review a new Colorcon Technical Paper offering a summary of key points presented in the recent US Center for Drug Evaluation and Research (CDER) Guidance...

Amino Acid Analysis of Pharmaceutical Products

SGS Life Science Services | 11-Jul-2016 | Technical / White Paper

Amino Acid Analysis in general can be used for identification testing of biopharmaceutical active ingredients and the determination of impurities and related...

Rapid Microbiological Method Statistics & Validation

EMD Millipore | Recorded the 17-May-2016 | Webinar

It is well known that implementation of Rapid Microbiological Methods in Pharma environments is accompanied by a large validation workload to ensure that...

Live Webinar on Recent PAT applications for Softgels presented by Softigel by Procaps

Softigel by Procaps | Recorded the 30-Nov-2015 | Webinar

Process Analytical Technologies (PAT) in solid dosages forms are commonly used for tablets. Procaps brings to you this webinar intended to present PAT...

Article on Viral Clearance for Biopharmaceuticals

Catalent Pharma Solutions | 24-Aug-2015 | Technical / White Paper

Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals.  These studies are a key component...

I Holland: Sharing our knowledge and experience

I Holland Limited - Tabletting Science | 01-Feb-2015 | Event Programme

Maintenance training, seminars, our 7 Step Audit SOP and live webinars are a just few of the training opportunities I Holland have to offer. Click to find...

Customized Biosimilarity Analytical Testing from Catalent

Catalent Pharma Solutions | 26-Jan-2015 | Technical / White Paper

Assessment of biosimilar molecules requires an orthogonal analytical approach.  Any one particular analytical technique is not able to fully define the...

OptiPact™ Technology Introduced by Catalent

Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health...

Meaningful Metrics – A CMO Perspective

Patheon Inc | 19-Jan-2015 | Technical / White Paper

Learn about the roles of sponsors and their contract manufacturing organization (CMO) partners regarding metrics, what metrics to measure, how to manage...

USP<233> Elemental Impurities Sample Prep Strategy

SGS Life Science Services | 03-Nov-2014 | Technical / White Paper

Although USP <232> and <233> are still under discussion, a good deal of work is going on ahead of implementation in terms of method development....

Want to Strengthen Your Supply Chain Security?

Information not available | 18-Mar-2014 | Event Programme

The challenges of ensuring safe drugs for patients are universal, international and pervasive. The Global Forum on Access to Safe Medicines brings together...

Method Validation for Heavy Metals Testing

SGS Life Science Services | 04-Mar-2014 | Technical / White Paper

USP proposed <232> and <233> changes require ICP and ICP-MS instrumentation and methodology expertise, and knowledge of sample preparation....

Film Coating for Pediatric Oral Solid Dosage Forms

Colorcon Inc. | 14-Jan-2014 | Technical / White Paper

With careful selection, of an appropriate film coating system, pediatric products may be coated with a suitable color while also providing mechanical integrity,...

Method Development and Validation for Nutraceuticals

RSSL | 12-Dec-2013 | Technical / White Paper

Nutraceutical is a term formed from the amalgamation of the words “pharmaceutical” and “nutrition” by Dr Stephen Felice in 1989. Others have since tried...

Mitigating Medication Errors with Tablet Design

Colorcon Inc. | 09-Dec-2013 | Technical / White Paper

Medical prescription drug errors by doctors, pharmacists and patients account for 1.5 million incidences of sickness, injuries or deaths in the U.S. each...

Clinical Document distribution - Secure and Automated

pharmasol | 04-Nov-2013 | Case Study

psiXchange automates the distribution of your safety related documents. The distribution engine handles country specific rules and user specific escalation...

NEOBEE® MCTs Enhance Pharmaceutical Bioavailability

Stepan Lipid Nutrition | 04-Nov-2013 | Technical / White Paper

An efficient solvent for many lipophylic drugs and vitamins, NEOBEE® MCTs emulsify in aqueous environments and help uptake in intestinal cells. They are...

Analysis of Biopharmaceuticals to Conform to ICHQ6B

RSSL | 25-Sep-2013 | Technical / White Paper

Worldwide, the pharmaceuticals market is anticipated to grow from more than USD 782 billion in 2011 to approach a value of just over USD 971 billion by...

Cell Culture Media Identification with Handheld 1064 Nanometer Raman

Rigaku Raman Technologies | 23-Sep-2013 | Application Note

Biopharmaceutical production is a rapidly growing and high risk industry. According to a market research report, only three of ten drugs receive market...

Pharmaceutical Material Identification

Thermo Fisher Scientific | 18-Sep-2013

Thermo Scientific TruScan RM and microPHAZIR RX analyzers are revolutionary instruments that can help you achieve compliance and realize a rapid return...

Handheld 1064nm Raman boosts excipient analysis capacity

Rigaku Raman Technologies | 21-Aug-2013 | Application Note

Pharmaceutical manufacturers the world over seek more efficient technologies for materials validation. Implementation of handheld Raman spectrometers utilising...

Exploring New Frontiers in Direct to Patient Home Delivery Services for Clinical Trials Materials

Marken | Recorded the 10-Sep-2013 | Webinar

Exploring New Frontiers in Direct to Patient (DTP) Home Delivery Services for Clinical Trial Materials provides an in-depth look at reasons to consider...

Id Counterfeit Pharmaceuticals with Portable Raman

Rigaku Raman Technologies | 22-May-2013 | Technical / White Paper

The growing danger of counterfeit and substandard medicines entering the supply chain is a concern for global pharmaceutical manufacturers and consumers....

Increasing Accuracy, Not Costs

METTLER TOLEDO | 11-Apr-2013 | Case Study

Pharmaceutical manufacturers worldwide are turning to vision inspection as a way to safeguard their brands, keeping products with label and packaging defects...

White Paper: Is My Method Still Valid?

SGS Life Science Services | 26-Mar-2013 | Technical / White Paper

The goal of method validation is to pro­vide proof that data from each individual sample is indicative of the actual batch content with little deviation....

Optimizing your Strategy and Budget for Clinical Trial Supply Distribution

Marken | Recorded the 20-Mar-2013 | Webinar

How to determine if a depot or direct to site shipments are more efficientCalculation based on a case studyHow to avoid delays and assure that your shipments...

From the Loading Dock to Quality Stock: Three Scenarios to Reduce Incoming Inspection Costs

Thermo Fisher Scientific | 26-Feb-2013 | Technical / White Paper

This whitepaper describes three scenarios that clearly demonstrate the value TruScan brings to pharmaceutical manufacturing facilities and the underlying...

Extractables & Leachables Risk Assessment

SGS Life Science Services | 04-Feb-2013 | Technical / White Paper

An extractables and leachables case study describes how a comprehensive risk assessment was performed across the entire production process of a European...

Partnering with Your CDMO for CMC Preparation

DPT Laboratories | 26-Sep-2012 | Insight Guide

Collaborative partnering between Contract Development and Manufacturing Organizations (CDMO) and the drug product submission applicants is becoming increasingly...

Radio Ion Chromatography

Metrohm – customized analysis for the pharmaceutical industry | 17-Sep-2012 | Data Sheet

Radio Ion ChromatographyPositron emission tomography (PET) is one of the most powerful noninvasive diagnostic tools for tracing organ functioning. Quality...